Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- number of participants developing delirium post-operatively
研究概览
简要总结
The purpose of this study is compare the rates of post-operative delirium between a group of people receiving intravenous (IV) pain control after hip fracture surgery and a group of people receiving a femoral nerve catheter for pain control. Post-operative delirium is confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the group receiving the femoral nerve catheter for pain may have a lower incidence of delirium than the group receiveing IV pain medication.
详细描述
Subjects will have their hearing and vision tested. They will have their ability to think and analyze information tested using 4 questionnaires/ surveys: The Confusion Assesment Method (CAM), the Mini-Mental Status Examination (MMSE), Modified Blessed Dementia scale (MBDS), and Barthel's Activities of Daily Living (ADL). They will have pain medication prior to surgery based on the doctor's orders.
On the day of surgery, subjects will be randomized (like a flip of a coin) into one of two groups. One group will receive IV medication to control for pain after surgery. The other group will receive a femoral nerve catheter to control for pain after surgery.
A femoral nerve catheter is the small tubing that delivers numbing medicine to the nerves around the hips that control pain. This will be placed either before, during or soon after your surgery to help with pain after the surgery. This catheter is placed using an ultrasound machine. Subjects will still have pain medication through the IV before surgery if the catheter is put into their leg.
After surgery, you will be given the pain medication either through the IV or through the catheter in your leg. The catheter will be left in after surgery for 2-3 days delivering numbing medicine to the nerves. If subjects have the catheter in their leg and need more pain medication, the medication will be given to them through the IV.
Subjects will be visited by a member of the study staff on the second and third day after surgery. The study staff member will ask questions about the subject's ability to think and analyze information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 and older
- •Presenting to Ochsner Main Campus with a hip fracture
排除标准
- •Head trauma as reported in the medical record and/or patient response
- •High impact fractures as reported in the medical record
- •Aphasia as reported in the medical record and/or patient response
- •Deafness, blindness as reported in the medical record and/or patient response
- •True allergy (not sensitivity or side effects) to local anesthetics or opiates
- •Inability to complete study activities pre-operatively
结局指标
主要结局
number of participants developing delirium post-operatively
时间窗: 3 days post-operatively
次要结局
- the number of days admitted to the hospital post-operatively(participants will be followed for the duration of the hospital stay, an expected average of 4 days)
- Is there a difference in pain scores between subjects receiving the femoral nerve catheter vs. opioid only therapy for hip fracture pain using the visual analog scale (VAS) and consumption of pain medication for breakthrough pain relief?(post-op day 2 and again on post-op day 3)
研究者
Leslie Thomas
Anesthesiologist
Ochsner Health System